Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201

NCT ID: NCT05470881

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-20
• Study Completion Date: 2022-12-26

Brief Summary

Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its instillation on the ocular surface of healthy volunteers through the following variables: unexpected adverse events incidence and photophobia (primary outcome variables); as well as pupillary diameter, expected adverse events incidence, best near corrected visual acuity (BNCVA), best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal and conjunctival staining, heart rate, blood pressure and ocular confort index (OCI),

Detailed Description

A total of 29 healthy volunteers will be enrolled in this study. They will receive one drop of the investigation product PRO-201 (0.01% atropine sulfate) once a day (QD) for a total of 14 days on both eyes. A final safety call will be performed one week after the last day of product application.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRO-201

A total of 29 anticipated healthy volunteers will be exposed to the investigation product.

Group Type: EXPERIMENTAL

Atropine Sulfate

Intervention Type: DRUG

Administration of one drop QD on both eyes for 14 days.

Interventions

Atropine Sulfate

Administration of one drop QD on both eyes for 14 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Being clinically healthy
• Ability to voluntarily sign an informed consent form (ICF).
• Ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study.
• Age between 18 and 35.
• Absence of history of contact lens use.
• Women of childbearing age must agree to continue (starting ≥ 30 days previous to the ICF) the use of a hormonal contraception method of a intrauterine device (IUD) during the period of the study.
• Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in both eyes.
• Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better in both eyes.
• Presenting vital signs within normal parameters.
• Presenting an IOP ≥10 and ≤ 21 mmHg

Exclusion Criteria

• Using any kind of ophthalmic topical products.
• Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents.
• Using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration
• For women: being pregnant, breastfeeding or planning to get pregnant during the period of the study.
• Having participated in any clinical study 90 days prior to the inclusion in this study.
• Having participated in this clinical study.
• Inability to follow the lifestyle considerations of this study.
• History of any chronic degenerative disease, including diabetes and hypertension.
• Presenting active inflammatory or infectious diseases when entering this study.
• Presenting unresolved lesions or trauma when entering this study.
• History of any ocular surgery.
• History of any surgery, non-ocular, within the previous 3 months of entering this studies.
• Being or having an direct family member (spouse, parent/legal guardian, sibling, etc) as employee of the investigation site or the sponsor, who participates directly in this study.

Elimination criteria:

• Withdraw of ICF.
• Adverse event, related or not to the investigation product, that according to the principal investigator and/or the sponsor may affect the integrity of the patient to continue safely with the study's procedures.
• Hypersensitivity or lack of tolerance to any of the ingredients used during the study's procedures (fluorescein, lissamine green, tetracaine, etc)
• Hypersensitivity or lack of tolerance to the investigation product.
• Presenting an adherence to treatment < 90%, as determined through the subjects diary.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratorios Sophia S.A de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IIMET Investigación e Innovación en Medicina Traslacional

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

SOPH201-0521/I

Identifier Type: -

Identifier Source: org_study_id